A Phase II Study of Treatment of Brain Metastases From Non-Small Cell Lung Cancer With Concurrent Whole Brain Radiation Therapy and Pemetrexed
18 Years
N/A
Both
Lung Cancer, Metastatic Cancer
Trial Information
A Phase II Study of Treatment of Brain Metastases From Non-Small Cell Lung Cancer With Concurrent Whole Brain Radiation Therapy and Pemetrexed
OBJECTIVES:
Primary
- Estimate the response in patients with intracranial brain metastases from non-small
cell lung cancer treated with whole-brain radiotherapy and pemetrexed disodium.
Secondary
- Determine the toxicity of this regimen in these patients.
- Estimate the overall survival of patients treated with this regimen.
- Evaluate the functional status of patients treated with this regimen.
- Assess neurological function and progression in patients treated with this regimen.
- Determine the response of patients with extracranial disease treated with pemetrexed
disodium.
OUTLINE: Patients undergo whole-brain radiotherapy 5 days a week for 3 weeks beginning on
day 1. Patients also receive pemetrexed disodium IV on day 1, 2, or 3 and day 28 of course
1, and on day 1 of each subsequent course. Treatment with pemetrexed disodium repeats every
21 days for a total of 4 courses in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed at 30 days and then every 2
months for 2 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Must have evidence of brain metastases by MRI or CT scan
- No single brain metastases or oligometastatic disease amenable to surgical
resection or radiosurgery
- Relapsed NSCLC with brain metastases allowed
- Not a candidate for double-agent or platinum-based chemotherapy
- No leptomeningeal metastases
- No clinically relevant (defined by physical exam) pleural effusions or ascites that
cannot be controlled with drainage or other procedures
PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100% OR ≥ 70 years of age
- Life expectancy > 3 months
- ANC > 1,500/mm³
- Platelet count > 100,000/mm³
- Hemoglobin ≥ 8 g/dL
- AST and ALT < 3 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
- Creatinine clearance ≥ 45 mL/min
- No contraindication or intolerance to corticosteroid therapy
- No other malignancies within the past 5 years and disease-free OR prognosis is best
defined by the NSCLC in the opinion of the attending physician
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No HIV positivity
- No severe hypersensitivity to pemetrexed disodium
- Able to discontinue NSAIDs for ≥ 5 days
- No history of underlying dementia, Parkinson's disease, or Alzheimer's disease
- Able to take vitamins, folic acid, and corticosteroids
PRIOR CONCURRENT THERAPY:
- Recovered from prior oncologic or major surgery
- Prior resection of all brain metastases or only site of brain metastases allowed
provided there is radiologically evaluable intracranial metastases
- No prior cranial irradiation, including stereotactic radiosurgery
- More than 30 days since prior nonapproved or investigational drug
- No other concurrent chemotherapy, immunotherapy, hormonal therapy, radiotherapy,
surgery, or experimental medications
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response of intracranial metastases (complete and partial response)
Outcome Description:
Radiographic response will be measured by RECIST, indicating if subject experienced a Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD)
Outcome Time Frame:
126 days
Safety Issue:
No
Principal Investigator
Thomas E. Stinchcombe, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
UNC Lineberger Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
LCCC 0409
NCT ID:
NCT00280748
Start Date:
May 2005
Completion Date:
April 2009
Related Keywords:
- Lung Cancer
- Metastatic Cancer
- recurrent non-small cell lung cancer
- stage IV non-small cell lung cancer
- tumors metastatic to brain
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
- Neoplasm Metastasis
- Neoplasms
- Neoplasms, Second Primary
Name | Location |
|---|---|
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
| Alamance Oncology/Hematology Associates, LLP | Burlington, North Carolina 27216 |
